This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the diasorin eti-mak-2 plus assay. The device is indicated for: eti-mak-2 plus is an in vitro enzyme immunoassay (eia) intended for use in the qualitative determination of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, citrate or heparin). The eti-mak-2 plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of hbsag is indicative of a laboratory diagnosis for hepatitis b virus (hbv) infection, either acute or chronic. Further hbv serological marker testing is required to define the specific disease state. The eti-mak-2 plus assay's performance has not been established for the monitoring of hbv disease or therapy. This assay has not been fda-approved for the screening of blood or plasma donors.
| Device | DIASORIN ETI MAK-2 PLUS ASSAY |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DIASORIN, INC. |
| Date Received | 1999-07-02 |
| Decision Date | 2001-03-30 |
| Notice Date | 2001-10-09 |
| PMA | P990038 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 01M-0451 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DIASORIN, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990038 | Original Filing | |
| S032 | 2021-11-23 | 30-day Notice |
| S031 | 2020-07-16 | 30-day Notice |
| S030 | 2019-08-28 | 30-day Notice |
| S029 | 2019-06-18 | 30-day Notice |
| S028 | 2018-05-30 | 30-day Notice |
| S027 | 2018-03-30 | 30-day Notice |
| S026 | ||
| S025 | 2018-02-14 | 30-day Notice |
| S024 | 2017-09-18 | 30-day Notice |
| S023 | 2017-04-25 | 30-day Notice |
| S022 | 2017-03-29 | 30-day Notice |
| S021 | 2016-05-10 | 30-day Notice |
| S020 | 2014-06-05 | 30-day Notice |
| S019 | 2013-12-27 | 30-day Notice |
| S018 | 2013-06-05 | 30-day Notice |
| S017 | 2012-11-09 | Special (immediate Track) |
| S016 | ||
| S015 | 2012-02-17 | 30-day Notice |
| S014 | 2011-10-18 | 30-day Notice |
| S013 | 2009-11-13 | 135 Review Track For 30-day Notice |
| S012 | 2009-11-13 | Real-time Process |
| S011 | 2006-03-24 | Special (immediate Track) |
| S010 | 2005-06-03 | 30-day Notice |
| S009 | ||
| S008 | 2004-04-23 | 30-day Notice |
| S007 | 2004-04-05 | 30-day Notice |
| S006 | 2004-04-05 | 30-day Notice |
| S005 | 2003-07-16 | Special (immediate Track) |
| S004 | 2002-10-29 | Normal 180 Day Track |
| S003 | 2002-10-17 | 30-day Notice |
| S002 | 2002-01-16 | Normal 180 Day Track |
| S001 |